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https://hdl.handle.net/2440/73741
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dc.contributor.author | Richmond, P. | - |
dc.contributor.author | Nissen, M. | - |
dc.contributor.author | Marshall, H. | - |
dc.contributor.author | Lambert, S. | - |
dc.contributor.author | Roberton, D. | - |
dc.contributor.author | Gruber, W. | - |
dc.contributor.author | Jones, T. | - |
dc.contributor.author | Arora, A. | - |
dc.date.issued | 2012 | - |
dc.identifier.citation | Vaccine, 2012; 30(43):6163-6174 | - |
dc.identifier.issn | 0264-410X | - |
dc.identifier.issn | 0264-410X | - |
dc.identifier.uri | http://hdl.handle.net/2440/73741 | - |
dc.description.abstract | Neisseria meningitidis is a leading cause of meningitis and septicaemia, but a broadly-protective vaccine against endemic serogroup B disease is not licensed and available. The conserved, outer-membrane lipoprotein factor H binding protein (fHBP, also known as LP2086) is expressed as one of two subfamily variants in virtually all meningococci. This study investigated the safety, tolerability, and immunogenicity of a recombinant-expressed bivalent fHBP (r-fHBP) vaccine in healthy adults. Participants (N=103) aged 18-25 years were recruited into three ascending dose level cohorts of 20, 60, and 200μg of a bivalent r-fHBP vaccine formulation and randomised to receive vaccine or placebo at 0, 1, and 6 months. The vaccine was well tolerated. Geometric mean titres (GMTs) for r-fHBP subfamily-specific IgG antibodies increased 19-168-fold from pre-vaccination to post-dose 2 in a dose level-dependent manner. In addition, robust serum bactericidal assay using human complement (hSBA) responses for strains expressing both homologous and heterologous fHBP variants were observed. After three vaccinations, 16-52% of the placebo group and 47-90%, 75-100%, and 88-100%, of the 20, 60, and 200μg dose levels, respectively, had seroprotective (≥ 1:4) hSBA titres against six serogroup B strains. The bivalent r-fHBP vaccine was well tolerated and induced robust bactericidal activity against six diverse serogroup B strains in young adults at the 60 and 200μg dose levels. | - |
dc.description.statementofresponsibility | P.C. Richmond, M.D. Nissen, H.S. Marshall, S.B. Lambert, D. Roberton, W.C. Gruber, T.R. Jones and A. Arora | - |
dc.language.iso | en | - |
dc.publisher | Elsevier Sci Ltd | - |
dc.rights | © 2012 Elsevier Ltd. | - |
dc.source.uri | http://dx.doi.org/10.1016/j.vaccine.2012.07.065 | - |
dc.subject | Humans | - |
dc.subject | Neisseria meningitidis, Serogroup B | - |
dc.subject | Meningococcal Infections | - |
dc.subject | Bacterial Proteins | - |
dc.subject | Immunoglobulin G | - |
dc.subject | Vaccines, Synthetic | - |
dc.subject | Meningococcal Vaccines | - |
dc.subject | Antibodies, Bacterial | - |
dc.subject | Antigens, Bacterial | - |
dc.subject | Double-Blind Method | - |
dc.subject | Adult | - |
dc.subject | Complement System Proteins | - |
dc.subject | Female | - |
dc.subject | Male | - |
dc.subject | Young Adult | - |
dc.subject | Serum Bactericidal Antibody Assay | - |
dc.title | A bivalent Neisserie meningitidis recombinant lipidated factor H binding protein vaccine in young adults: results of a randomised, controlled, dose-escalation phase 1 trial | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1016/j.vaccine.2012.07.065 | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Marshall, H. [0000-0003-2521-5166] | - |
Appears in Collections: | Aurora harvest 4 Paediatrics publications |
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